Clinical trial · Interventional
Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique
Robotic Nipple-Sparing Mastectomy And Immediate Robotic Breast Reconstruction Vs Conventional Open Technique: A Prospective Randomized Trial Evaluating Patients Satisfaction
NCT03440398CI-TRIAL-00106319completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with conventional open technique. It is a prospective randomized trial evaluating patients satisfaction
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open NSM | Procedure | — | UNRESOLVED |
| Robotic NSM | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Open NSM
- description
- Conventional Nipple Sparing Mastectomy
- interventionNames
- Procedure: Open NSM
- type
- EXPERIMENTAL
- label
- Robotic NSM
- description
- Robotic Nipple-Sparing Mastectomy
- interventionNames
- Procedure: Robotic NSM
Primary outcomes (1)
- measure
- Patient satisfaction
- timeFrame
- 1 year
- description
- The BREAST-Q survey is used to detect differences in patient satisfaction among the groups
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Invasive breast cancer, Ductal Carcinoma In Situ, Breast Related Cancer Antigens mutation carriers. * Any age * Candidates to nipple-sparing mastectomy and immediate breast reconstruction * Negative preoperative assessment of nipple-areola complex * Absence of skin involvement * Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section * Breast volume ≤ Bra IV; from cup A to D * No hard smoking (hard smoking defined as \>20 cigarettes/day) * Low and intermediate risk for anesthesia (ASA Scale) * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion * Patients must be accessible for follow-up Exclusion criteria: * Previous thoracic radiation therapy for any reason * Inflammatory Breast Cancer * Skin involvement * Pre-operative diagnosis (radiological or cytological) of nipple-areola complex disease * Pregnancy * Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study * Uncompensated Diabetes Mellitus * Hard smokers (hard smoking defined as \>20 cigarettes/day) * High risk for anesthesia
References
Publications (4)
- RESULTToesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2. PMID 27810700
- RESULTToesca A, Peradze N, Manconi A, Nevola Teixeira LF. Reply to the letter to the editor "Robotic-assisted Nipple Sparing Mastectomy: A feasibility study on cadaveric models" by Sarfati B. et al. J Plast Reconstr Aesthet Surg. 2017 Apr;70(4):558-560. doi: 10.1016/j.bjps.2016.12.022. Epub 2017 Jan 23. No abstract available. PMID 28153430
- RESULTToesca A, Peradze N, Galimberti V, Manconi A, Intra M, Gentilini O, Sances D, Negri D, Veronesi G, Rietjens M, Zurrida S, Luini A, Veronesi U, Veronesi P. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of Surgical Technique. Ann Surg. 2017 Aug;266(2):e28-e30. doi: 10.1097/SLA.0000000000001397. No abstract available. PMID 28692558
- DERIVEDToesca A, Sangalli C, Maisonneuve P, Massari G, Girardi A, Baker JL, Lissidini G, Invento A, Farante G, Corso G, Rietjens M, Peradze N, Gottardi A, Magnoni F, Bottiglieri L, Lazzeroni M, Montagna E, Labo P, Orecchia R, Galimberti V, Intra M, Sacchini V, Veronesi P. A Randomized Trial of Robotic Mastectomy Versus Open Surgery in Women With Breast Cancer or BrCA Mutation. Ann Surg. 2022 Jul 1;276(1):11-19. doi: 10.1097/SLA.0000000000004969. Epub 2021 Jun 9. PMID 34597010